A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su

Hoffmann-La Roche0 sites120 target enrollmentMay 2012

ConditionsHealthy Volunteer

Interventionsgantenerumab

Drugsgantenerumab

Overview

Phase: Phase 1
Intervention: gantenerumab
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 120
Primary Endpoint: Relative bioavailability: Area under the concentration-time curve
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
•Body mass index 18.0 to 30.0 kg/m2 inclusive
•Female subjects who are either surgically sterilized or post-menopausal
•Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing

Exclusion Criteria

•Suspicion of alcohol or drugs of abuse addiction
•Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
•Participation in an investigational drug or device study within three months before dosing
•Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
•Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
•Any familial history of early onset Alzheimer's disease
•Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan